TESARO Announces U.S. FDA Approval of ZEJULA™ (niraparib) for Women with Recurrent Ovarian Cancer

TESARO Announces U.S. FDA Approval of ZEJULA™ (niraparib) for Women with Recurrent Ovarian Cancer

WALTHAM, MA, March 27, 2017 – TESARO, Inc. (NASDAQ: TSRO), an oncology-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved ZEJULA™ (niraparib), an oral, once-daily poly(ADP-ribose) polymerase (PARP) inhibitor, for the maintenance treatment of women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response (CR or PR) to platinum based chemotherapy. ZEJULA is the first PARP inhibitor to be approved by the FDA that does not require BRCA mutation or other biomarker testing. TESARO anticipates launching ZEJULA in the United States in late April.

TESARO Announces U.S. FDA Approval of VARUBI™ (rolapitant) for Nausea and Vomiting Associated with Cancer Chemotherapy

Waltham, Mass., Sept. 2, 2015 – TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved VARUBI™ (rolapitant) in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy.

TESARO Announces Submission of Rolapitant New Drug Application (NDA) to U.S. Food and Drug Administration

WALTHAM, Mass., Sept. 8, 2014 (GLOBE NEWSWIRE) — TESARO, Inc. (Nasdaq:TSRO), an oncology-focused biopharmaceutical company, today announced that it has submitted the New Drug Application (NDA) for oral rolapitant to the U.S. Food and Drug Administration (FDA). Rolapitant is an investigational neurokinin-1 (NK-1) receptor antagonist developed for the prevention of chemotherapy-induced nausea and vomiting (CINV).

 

TESARO Announces Successful Achievement of Primary and All Secondary Endpoints in Third and Final Phase 3 Trial of Rolapitant

  • Achieved Primary Endpoint of Complete Response (CR) in the Delayed Period (24 to 120 Hours) Following Initiation of Chemotherapy
  • Achieved Key Secondary Endpoints of CR in the Acute and Overall Periods
  • Achieved All Secondary Endpoints, Including No Significant Nausea
  • Adverse Event Profile Consistent with Earlier Clinical Trials
  • New Drug Application (NDA) Submission to U.S. FDA On Track for Mid-2014

WALTHAM, Mass., May 12, 2014 (GLOBE NEWSWIRE) — TESARO, Inc. (Nasdaq:TSRO), an oncology-focused biopharmaceutical company, today announced positive top-line results from the third and final Phase 3 trial of rolapitant, an investigational neurokinin-1 (NK-1) receptor antagonist in development for the prevention of chemotherapy-induced nausea and vomiting (CINV). The rolapitant arm in this trial, which enrolled patients receiving cisplatin-based, highly emetogenic chemotherapy (HEC), successfully achieved statistical significance over the standard therapy arm for the primary and all secondary endpoints. The adverse event profile for rolapitant remains consistent with that seen in previous clinical studies.

TESARO Initiates Phase 3 Trial of Niraparib for Treatment of Patients with Ovarian Cancer

 
First Patients Enrolled in the NOVA Study

WALTHAM, Mass., July 23, 2013 (GLOBE NEWSWIRE) — TESARO, Inc. (Nasdaq:TSRO), an oncology-focused biopharmaceutical company, today announced that it has initiated patient enrollment in a Phase 3 trial of niraparib, an inhibitor of poly ADP-ribose polymerase (PARP), for the treatment of ovarian cancer. This trial, referred to as NOVA, will evaluate a single daily 300 milligram dose of niraparib in 360 patients with high grade serous, platinum sensitive, relapsed ovarian cancer compared to placebo.

TESARO Announces Presentation of Rolapitant Pharmacokinetic (PK) Data at the MASCC/ISOO International Symposium

 
PK Data from Drug-Drug Interaction Study Describes Lack of CYP3A4 Interactions

BERLIN, June 28, 2013 (GLOBE NEWSWIRE) — TESARO, Inc. (Nasdaq:TSRO), an oncology-focused biopharmaceutical company, today announced that results from a pharmacokinetic study of rolapitant, an NK-1 receptor antagonist, were presented this morning at the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) International Symposium in Berlin. These data support that rolapitant may be administered concomitantly with other pharmaceutical products that are metabolized by the liver microsomal enzyme CYP3A4, without a requirement for dose adjustment of the co-administered product. Pharmacokinetic data for other NK-1 receptor antagonists indicate that doses of concomitantly administered products metabolized by CYP3A4 must often be adjusted.

Tesaro raises $81M in a rare IPO success story

Just two years after getting started, the experienced cancer pros at Tesaro ($TSRO) have pulled off a successful IPO–a rarity in an industry that has been starved of IPO cash since 2007. On Thursday Tesaro made the switch to a public company, started trading at the middle of its range and actually went up a bit by the end of the day.

Tesaro, though, is different from many of the biotechs making a risky leap into the public markets these days. Its executive team, led by Lonnie Moulder, orchestrated the $3.9 billion sale of MGI Pharma. At Tesaro, they quickly raised $101 million in their second round, executing on a series of in-licensing deals for experimental cancer drugs.

There was one strategy in its IPO game plan that Tesaro shares with other newly public biotechs. It gained commitments from its insiders to buy up to $25 million in shares, helping to give its stock a boost as it came out of the gate.

The biotech–a 2011 Fierce 15 company–ended up selling 6 million shares at $13.50 a share, within its $12 to $15 range, raking in $81 million. Then it bumped up 1.4% by the end of the day. VC backers include New Enterprise Associates, set to become the largest shareholder with 39% of the stock, as well as Kleiner Perkins, Caufield Byers and Venrock.

Tesaro nabbed niraparib, a cancer drug in Merck’s ($MRK) pipeline, recently. It has also in-licensed rolapitant and pushed the cancer treatment into a Phase III study, with an eye to delivering top-line data in the second half of next year. An IND for TSR-011 as a new therapy for non-small cell lung cancer, in-licensed from Amgen ($AMGN) in the spring of last year, is being prepped for filing in the second half. 

Tesaro raises $81M in a rare IPO success story

 

June 29, 2012

Just two years after getting started, the experienced cancer pros at Tesaro ($TSRO) have pulled off a successful IPO–a rarity in an industry that has been starved of IPO cash since 2007. On Thursday Tesaro made the switch to a public company, started trading at the middle of its range and actually went up a bit by the end of the day.

Tesaro, though, is different from many of the biotechs making a risky leap into the public markets these days. Its executive team, led by Lonnie Moulder, orchestrated the $3.9 billion sale of MGI Pharma. At Tesaro, they quickly raised $101 million in their second round, executing on a series of in-licensing deals for experimental cancer drugs.

There was one strategy in its IPO game plan that Tesaro shares with other newly public biotechs. It gained commitments from its insiders to buy up to $25 million in shares, helping to give its stock a boost as it came out of the gate.

The biotech–a 2011 Fierce 15 company–ended up selling 6 million shares at $13.50 a share, within its $12 to $15 range, raking in $81 million. Then it bumped up 1.4% by the end of the day. VC backers include New Enterprise Associates, set to become the largest shareholder with 39% of the stock, as well as Kleiner Perkins, Caufield Byers and Venrock.

Tesaro nabbed niraparib, a cancer drug in Merck’s ($MRK) pipeline, recently. It has also in-licensed rolapitant and pushed the cancer treatment into a Phase III study, with an eye to delivering top-line data in the second half of next year. An IND for TSR-011 as a new therapy for non-small cell lung cancer, in-licensed from Amgen ($AMGN) in the spring of last year, is being prepped for filing in the second half.

Biotech All Stars Buy Castoff Experimental Merck Cancer Drug

Tesaro of Waltham, Mass., a tiny biotech now preparing for its initial public offering, just licensed a promising anti-cancer drug from Merck. The startup is attempting to repeat the success its top executives had turning Big Pharma’s castoffs into hits at MGI Pharma, which was bought by Eisai for $3.9 billion in 2008.

The drug, known as niraparib or MK-4827, is a medicine that targets a mutation that can cause certain hard-to-treat breast and ovarian cancers. AstraZeneca, Abbott Laboratories and Pfizer are also developing similar medicines. The deal was disclosed in a filing with the Securities and Exchange Commission.

At the same time that big drug companies are increasingly buying new medicines developed outside their own walls, they are also selling more of the medicines that they invent but don’t plan on developing to smaller biotechs. This has always happened – Cubist Pharmaceuticals’ antibiotic Cubicin was licensed from Eli Lilly more than a decade ago. But now it is becoming more commonplace, with Pfizer, for instance, talking about the option of selling experimental drugs to outside companies as a central part of its strategy.

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Biotech All Stars Buy Castoff Experimental Merck Cancer Drug

 
June 6,2012

Tesaro of Waltham, Mass., a tiny biotech now preparing for its initial public offering, just licensed a promising anti-cancer drug from Merck. The startup is attempting to repeat the success its top executives had turning Big Pharma’s castoffs into hits at MGI Pharma, which was bought by Eisai for $3.9 billion in 2008.

The drug, known as niraparib or MK-4827, is a medicine that targets a mutation that can cause certain hard-to-treat breast and ovarian cancers. AstraZeneca, Abbott Laboratories and Pfizer are also developing similar medicines. The deal was disclosed in a filing with the Securities and Exchange Commission.

At the same time that big drug companies are increasingly buying new medicines developed outside their own walls, they are also selling more of the medicines that they invent but don’t plan on developing to smaller biotechs. This has always happened – Cubist Pharmaceuticals’ antibiotic Cubicin was licensed from Eli Lilly more than a decade ago. But now it is becoming more commonplace, with Pfizer, for instance, talking about the option of selling experimental drugs to outside companies as a central part of its strategy.